Molecular Partners Shares Rise 37% Premarket After Trial Meets Primary Endpoint
January 10 2022 - 7:06AM
Dow Jones News
By Chris Wack
Molecular Partners AG shares rose 37% to $22.60 in premarket
trading after the company and Novartis said that Part A of their
clinical trial comparing single intravenous doses of ensovibep, a
DARPin antiviral therapeutic candidate, versus placebo to treat
Covid-19, met the primary endpoint of viral load reduction over
eight days.
The company said the two secondary endpoints in the study also
showed clinically meaningful benefit over placebo: composite
endpoint of hospitalization and/or Emergency Room visits or death,
and time to sustained clinical recovery.
Novartis said it will exercise its option to in-license
ensovibep from Molecular Partners and, following exercise of the
option, will seek expedited access globally, first via the Food and
Drug Administration's EUA process.
The clinical trial, which is being conducted by Novartis, with
Molecular Partners as sponsor, is a placebo controlled study in
ambulatory adult patients with Covid-19. Part A enrolled 407
patients to identify a dose of ensovibep with optimal safety and
efficacy and recruited patients in the U.S., South Africa, India,
the Netherlands, and Hungary to explore three doses: 75mg, 225mg
and 600mg.
Results from the study showed that the primary endpoint was met
with a statistically significant reduction in viral load over eight
days, compared to placebo, for all three dosing arms. The secondary
endpoint of hospitalization and/or ER visits related to Covid-19,
showed an overall 78% reduction in risk of events across ensovibep
arms compared to placebo. No deaths occurred in any of the patients
treated with ensovibep. All doses were well-tolerated and no
unexpected safety issues were identified for any of the doses.
Novartis told Molecular Partners of its intent to option its
exclusive license to global rights of ensovibep, which will lead to
a milestone payment. Molecular Partners will also be eligible to
receive 22% royalty on sales. Molecular Partners has agreed to
forgo royalties in lower income countries and is aligned with
Novartis' plans to ensure affordability based on countries' needs
and capabilities.
Novartis will become responsible for development, manufacturing,
distribution and commercialization activities of ensovibep.
Novartis has initiated scale-up activities in its large-scale
biologics production facilities.
Molecular Partners estimates its cash runway to extend into
2025, excluding any potential royalty income as well as excluding
potential further cash flows.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
January 10, 2022 06:51 ET (11:51 GMT)
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